[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3455 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3455

   To allow for expedited approval of generic prescription drugs and 
      temporary importation of prescription drugs in the case of 
            noncompetitive drug markets and drug shortages.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 28, 2016

Ms. Klobuchar (for herself and Mr. Lee) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To allow for expedited approval of generic prescription drugs and 
      temporary importation of prescription drugs in the case of 
            noncompetitive drug markets and drug shortages.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Supply and Value 
Enhancement Act'' or the ``Pharmaceutical SAVE Act''.

SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION DRUGS.

    (a) Temporary Importation.--Section 506C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356c) is amended--
            (1) by redesignating subsections (h) and (i) as subsections 
        (i) and (j), respectively; and
            (2) by inserting after subsection (g) the following:
    ``(h) Temporary Importation Authority.--
            ``(1) In general.--If, based on notifications described in 
        subsection (a) or any other relevant information, the Secretary 
        concludes that there is, or is likely to be, a drug shortage of 
        a drug described in subsection (a), except as provided in 
        paragraph (3), the Secretary shall authorize importation of 
        such drug for a period of up to 3 years if--
                    ``(A) the drug is a drug subject to section 
                503(b)(1), other than a drug described in subparagraphs 
                (A) through (F) of section 804(a)(3);
                    ``(B) the drug is authorized to be lawfully 
                marketed in one or more of the countries included in 
                the list under section 802(b)(1);
                    ``(C) the imported drug has the same active 
                ingredient as the drug for which there is a shortage 
                described in subsection (i)(2)(B) with respect to 
                manufacturers in the United States;
                    ``(D) the manufacturer certifies to the Secretary 
                that it intends to seek approval of the drug under 
                section 505(j); and
                    ``(E) an importer (as defined in section 804(a)) 
                files with the Secretary information--
                            ``(i) attesting that the requirements under 
                        subparagraphs (A) through (D) are satisfied;
                            ``(ii) identifying the drug the importer 
                        proposes to import and the manufacturer from 
                        whom the importer proposes to import such drug; 
                        and
                            ``(iii) requesting authority to import the 
                        drug.
            ``(2) Beginning date of importation.--If all of the 
        conditions under paragraph (1) are met, the Secretary shall 
        authorize importation of a drug in accordance with such 
        paragraph beginning not later than 60 days after receipt of the 
        information under paragraph (1)(E).
            ``(3) Discretionary denial of importation.--The Secretary 
        may deny importation of a drug otherwise qualified for 
        importation under paragraph (1) if the Secretary determines 
        that--
                    ``(A) the drug is not safe and effective;
                    ``(B) the drug is used in conjunction with a device 
                for which there is no reasonable assurance of safety 
                and effectiveness; or
                    ``(C) the authorization to market the drug in one 
                or more of the countries included in the list under 
                section 802(b)(1) has been rescinded or withdrawn 
                because of any concern relating to the safety or 
                effectiveness of the drug.
            ``(4) Termination of authority.--The authority to import a 
        drug pursuant to paragraph (1) shall terminate after 3 years, 
        or when the drug shortage no longer applies, whichever occurs 
        first.''.
    (b) Noncompetitive Drug Markets.--Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 506C-1 the following:

``SEC. 506C-2. NONCOMPETITIVE DRUG MARKETS.

    ``(a) In General.--If the Secretary determines under subsection (b) 
that a noncompetitive market exists with respect to an applicable drug, 
the Secretary--
            ``(1) shall treat such noncompetitive market as creating a 
        drug shortage for purposes of section 506C(g), and may expedite 
        the review of applications and inspections in accordance with 
        such subsection; and
            ``(2) shall treat such noncompetitive market as creating a 
        drug shortage for purposes of section 506C(h), and shall 
        authorize importation of the drug in accordance with such 
        subsection.
    ``(b) Determination of Noncompetitive Market.--
            ``(1) In general.--The Secretary shall determine that a 
        noncompetitive market exists with respect to an applicable drug 
        if--
                    ``(A) for at least 2 consecutive months prior to 
                the determination, fewer than 5 drugs approved under 
                section 505(c) (referred to in this paragraph as the 
                `applicable listed drug') or under section 505(j) that 
                reference the applicable listed drug were commercially 
                available in the United States;
                    ``(B) the applicable listed drug was approved at 
                least 10 years before such determination; and
                    ``(C) each patent which claims an active ingredient 
                of the applicable listed drug has expired.
            ``(2) Commercially available.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(A), a drug is not commercially available in the 
                United States if--
                            ``(i) the holder of an application approved 
                        under subsection (c) or (j) of section 505 has 
                        publicly announced that it has discontinued the 
                        manufacturing of the drug;
                            ``(ii) a drug approved under subsection (c) 
                        or (j) of section 505 has been withdrawn or 
                        discontinued; or
                            ``(iii) the Secretary has any other 
                        reasonable basis to conclude that a drug 
                        approved under subsection (c) or (j) of section 
                        505 is not competitively relevant.
                    ``(B) Holder of approved application.--In 
                determining whether 5 drugs are commercially available 
                under paragraph (1)(A), in the case of a single person 
                who is the holder of more than 1 application approved 
                as described in paragraph (1)(A) with respect to an 
                applicable drug, only 1 such drug shall be considered 
                to be commercially available.
    ``(c) Applicable Drug.--In this section, the term `applicable drug' 
means a drug that is not a radio pharmaceutical drug product or any 
other product as designated by the Secretary.''.
    (c) Annual Reporting on Drug Shortages.--Section 506C-1(a)(3)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(3)(B)) is 
amended--
            (1) in clause (i), by striking ``; and'' and inserting 
        ``;'';
            (2) in clause (ii), by adding ``and'' after the semicolon; 
        and
            (3) by inserting after clause (ii) the following:
                    ``(iii) the number of drugs authorized for 
                temporary importation under section 506C(h);''.
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